The overall purpose of this post is to undertake research and clinical trials under the human infection (challenge) platform. This will need to be undertaken under good clinical practice ensuring compliance with regulatory, statutory and programme policies in the performance and conduct of clinical trials, patient management including other related clinical and/or research activities and execution of research studies.
The post holder will be responsible for day-to-day oversight of the clinical trials and clinical research activities, develop research ideas. The post holder will work as clinical lead on the project(s) to ensure safety and clinical care of all study volunteers; contribute to tasks preparatory to the project(s), where applicable, to tasks including developing and submitting protocols, developing study work plans, organising, and conducting training for project-specific staff; and ensure compliance of all study staff to good clinical practices and procedures. The post-holder will aid day-to-day organisation and coordination of the research studies and trials, leading safety monitoring on clinical trials, lead and contribute to protocol and SOP development, and day-to-day supervision of clinical staff. Although these are the primary responsibilities, the post-holder will also be involved in higher level responsibilities for ensuring all clinical activities and procedures are carried out to quality standards, managing, and leading the clinical team whilst expected to share the load and as guided by the PI.
This post is open to qualified doctors with a PhD in a relevant field with research experience and will be funded for a three-year period. The post-holder is expected to develop clinical research methods and to execute programme management as well as roles in data management, sample/specimen management, data analysis, and report writing and scientific dissemination through publication writing and presentations. The post is demanding, involving attention to detail and timescales, and strong engagement with various stakeholders and collaborators.
- Principal investigator
- Research medical officers, Clinical Officers, and nurses
- Study coordinator
Will be responsible for managing budget allocated to clinical trial activities, work planning and task allocation, requisition and procurement of supplies, consumables and ensuring sensible use of resources.
The KEMRI-Wellcome Trust Research Programme (KWTRP) conducts high quality research on diseases with the highest burden in developing countries. The programme is recognised internationally within the fields of international public health, clinical tropical medicine, epidemiology, and immunology. The programme aims to maximise opportunities for learning and training to maintain a cadre of highly skilled and experienced staff from all disciplines.
The human infection (challenge) platform currently comprises of conducting clinical trials in two disease areas, malaria and Shigella with the aim of aim of accelerating vaccine development through evaluation of investigational products such as vaccines, identifying correlates of protection and/or correlates of immunity, and understanding of naturally acquired immunity. This involves the deliberate infection of healthy volunteers with infection causing agents (e.g., malaria and Shigella).
The post holder will need to be self-sufficient and be able to work with minimal supervision against demanding yet often unpredictable timelines. The post is mentally demanding and involves a high level of communication. The post holder may also be required to contribute to other linked projects.
The post-holder will be based in Kilifi working within an experienced team and research group.
- Independently oversee and coordinate all clinical activities according to GCP and protocol requirements.
- Prepare and execute research plans in liaison with other teams including those in the laboratories, data management and international collaborating partners.
- Take the lead in/contribute to study/clinical trial set up, identification of resource requirements, documentation of protocols, staff training, and grading and identification of adverse events etc.
- Work with the clinical team and researchers to provide good quality clinical care of study volunteers.
- Supervise and mentor other study team members, i.e., research medical officers, clinical officers, nurses, etc.
- Ensure that the rights, safety, and welfare of the study volunteers are protected, and clinical trial activities are conducted in accordance with the protocol, GCP and the regulatory guidelines. Ensuring adherence to the clinical SOPs regarding clinical and laboratory investigations of the volunteers in the study.
- Lead the collection, processing, compilation, and analysis of study data/samples and ensure all related records and reports are handled and managed in line with study protocols.
- Prepare, analyse, and present research summaries to Kilifi County public health staff, international collaborators, sponsors and at international conferences and meetings.
- Liaise with data management teams to ensure that all data is entered into relevant databases on time and verified.
- Carry out data analysis and interpretation and provide relevant matrices/ information including statistics, summaries, charts, graphs, reports, presentations etc.
- Prepare and submit draft reports as required including activity reports, project progress reports etc.
- Attend and actively participate in investigator’s meetings and other meetings within the research group, department, and programme e.g., journal clubs/seminars as needed.
- To participate in manuscript preparation, grant development, among other scientific roles
- Support and provide scientific mentorship and supervision of students working in the project.
- And any other duties that may be assigned by supervisors from time to time.
- PhD in a biomedical subject or any other relevant field.
- Bachelor of Medicine and Bachelor of Surgery (M.B;Ch.B.) degree or another related field.
- Upto 4 years Post-Doctoral experience.
- Eligibility for registration with the Kenya Medical Practitioners and Dentists Board .
- Proven record of experience with human subject’s research or demonstrable active interest and/or experience in biomedical research. Work on clinical trials or observational studies is an added advantage.
- Working experience in data analysis and use of statistical analysis software such as STATA or R.
- Significant skills in leadership, organisation, prioritisation, problem solving and decision making.
- Ability to network, communicate, resolving disputes, and maintain good working relationships within a multi-cultural environment.
- Ability to lead and work within a team.
- Training in ICH-GCP.
- Experience/qualification in adult medicine (clinical or research).
- Experience/qualification in basic biostatistics and clinical research.
- 1-2 years’ experience in clinical trials.
- Training in adult life support (basic and/or advanced).
- Current passport and ability to travel for international meetings
- Demonstrated high levels of confidentiality and integrity
- Excellent interpersonal, written, presentation, and communication skills
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong Management, leadership, and decision-making skills.
- Ability to build strong and diverse effective teams, delegation, and team motivation.
- Ability to build productive and collaborative relationships with various stakeholders
- Ability to work independently with minimal supervision.
PHYSICAL ENVIRONMENT/ CONDITIONS:
- Based at the KEMRI/Wellcome Trust Research Programme in Kilifi and be available to work out of hours where necessary.
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All applicants are required to state their current/last salary.
Candidates must supply an email and telephone contact that will be used when offering interviews. Only shortlisted candidates will be contacted. Shortlisted candidates shall be required to produce ORIGINALS of their National Identity Card, academic and professional certificates, original transcripts and testimonials, detailed curriculum vitae and valid clearance certificate (certificate of good conduct) during the interviews.
The application closing date is 11 November, 2022.
KEMRI-Wellcome Trust Research Programme (KWTRP) is an equal opportunity employer. Direct or indirect canvassing will lead to automatic disqualification. KWTRP does not charge a fee at any stage of the recruitment process (application, interview, meeting, processing, training or any other fees).